Wound HealingNCT06777069
Effect of Leucocyte- and Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting
A study testing Leucocyte and platelet rich fibrin membrane application in people with Wound Healing, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Autogenous palatal free gingival graft harvesting presents challenges for patients due to the increased risk of postoperative morbidity related to a second intraoral surgical wound that heals with secondary intention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Leucocyte and platelet rich fibrin membrane application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva (shallow vestibular depth, gingival recession)
Who cannot join
- Patients under 18 years of age
- Patients with systemic medical conditions that may compromise wound healing (e.g., uncontrolled diabetes mellitus, hypertension, blood disorders, rheumatoid arthritis)
- Patients receiving medication that may affect periodontal tissues (e.g., antibiotics, immunomodulatory drugs, steroids, non-steroidal anti-inflammatory drugs) within the last 3 months before surgery
- Patients receiving anticoagulant and antiaggregant therapy
- Smokers
- Pregnancy or breastfeeding
- History of palatal free gingival graft harvesting procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University, Faculty of Dentistry, Çankaya/Ankara
Ankara, 06490
About this study
Official title: Enhanced Palatal Wound Healing With Leucocyte- and Platelet-Rich Fibrin After Free Gingival Graft Harvesting: A Controlled Prospective Clinical Trial
Autogenous palatal free gingival graft harvesting presents challenges for patients due to the increased risk of postoperative morbidity related to a second intraoral surgical wound that heals with secondary intention. This study aimed to evaluate the efficacy of the application of leukocyte- and platelet-rich fibrin (L-PRF) membrane to the palatal donor site on wound healing, hemostasis, and pain control after free gingival graft harvesting. Twenty-six adult patients with insufficient attached gingiva underwent soft tissue augmentation using free gingival grafts harvested from the palate. Patients were randomized to either an L-PRF group or a control group. In the L-PRF group, the L-PRF membrane was sutured to the donor sites, whereas in the control group, donor sites healed by secondary intention. Postoperative evaluations were conducted on days 1, 3, 5, and 7 and at weeks 2, 3, 4, 5, and 6. Donor sites were evaluated clinically for pain, burning sensation, bleeding, wound healing, and color match to adjacent tissues. Donor site wound areas were analyzed using digital images.
Read the detailed description
Soft tissue grafting techniques using autogenous free gingival grafts and connective tissue grafts are reliable and predictable procedures that are commonly used to increase the dimensions of keratinized gingiva. These tehniques are indicated in situations such as shallow vestibular depth, gingival recession, and inadequate peri-implant attached gingiva. Although free soft tissue grafts can be harvested from various intraoral sites, the keratinized gingiva of the hard palate in the premolar-molar region is the most commonly used donor site. However, harvesting tissue from the palate presents challenges for patients, including a second intraoral surgical wound and an increased risk of postoperative morbidity. The palatal wound, which typically heals over two to four weeks by secondary intention, often causes significant patient discomfort due to pain, burning sensation, prolonged bleeding, and delayed healing, often caused by secondary irritation.
Leukocyte- and platelet-rich fibrin (L-PRF), a second-generation platelet concentrate, was developed for oral and maxillofacial surgery in 2001 by Choukroun et al. Polymerization without any biochemical activation, which occurs in a manner comparable to the natural coagulation process, produces a strong fibrin matrix resistant to rapid resorption. Compressing this fibrin matrix creates a strong, suture-resistant membrane that can be fixed to the wound edges and provides a stable barrier against the oral environment.
While L-PRF has shown promise in several applications in regenerative dentistry, randomized controlled clinical trials evaluating L-PRF membrane as an adjunct for donor site wound healing in free gingival grafting procedures are limited in the literature. This study aimed to evaluate the efficacy of L-PRF membrane as a palatal wound dressing in promoting wound healing, hemostasis, and pain control at palatal donor sites following free gingival grafting procedures.
Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva were included in this study. Patients were randomized to either an L-PRF group (n=13) or a control group (n=13). All procedures were performed by a single clinician to reduce variability in surgical technique. After achieving adequate anesthesia, a recipient site was prepared to receive the graft in areas lacking sufficient attached gingiva. This procedure involved an incision at the mucogingival junction followed by blunt dissection to separate the epithelium from the underlying connective tissue, creating a vascular bed for graft integration and survival. A sterile paper template was created to match the dimensions of the recipient site. The paper template was positioned on the palatal mucosa in the premolar/molar region, and the graft margins were outlined with a scalpel. A 1-2 mm thick graft consisting of epithelium and a thin layer of connective tissue was carefully harvested by moving the blade parallel to the mucosal surface. The free gingival graft was carefully oriented on the recipient site, with the epithelium facing outward and the connective tissue in contact with the recipient bed. It was then sutured to ensure close contact between the graft and the underlying tissue to prevent any movement that could compromise revascularization and lead to graft failure. In the L-PRF group, 10 ml of venous blood was drawn from the antecubital vein of the patient using sterile, anticoagulant-free vacutainer tubes and immediately centrifuged at 3000 rpm for 10 minutes. A fibrin clot was structured in the middle of the tube, just between the red corpuscles at the bottom and the acellular plasma at the top. The L-PRF layer was isolated and compressed into a flexible membrane using its special box. The L-PRF membrane was shaped to fit the donor site wound and placed as a single layer, ensuring complete contact with the underlying tissue. It was secured at the wound corners using 5-0 bioabsorbable polyglactin sutures to minimize displacement during the healing process.
Participants were evaluated on days 1, 3, 5, and 7, and weeks 2, 3, 4, 5, and 6 postoperatively to monitor wound healing and complications at the palatal donor site. An examiner recorded subjective parameters (pain, burning sensation), clinically evaluated objective parameters (postoperative bleeding, wound healing, and color matching with the adjacent healthy tissue), obtained donor site photographs, and performed wound area measurements using digital image analysis. Blinding of patients to L-PRF treatment was not feasible due to ethical concerns regarding the collection of blood samples in the control group, and blinding of investigators during digital image analysis and clinical assessment was also not feasible due to the nature of the surgical procedures.
- Conditions
- Wound Healing
- Being tested
- Leucocyte and platelet rich fibrin membrane application
- Keywords
- free gingival graft, platelet rich fibrin, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucocyte and platelet rich fibrin membrane applicationProcedure or surgery
Leukocyte and platelet rich membrane, obtained by centrifuging 10 ml of venous blood collected from the patient's antecubital vein, was sutured to the donor sites.
| Study group | Role | What they receive |
|---|---|---|
| Leucocyte and platelet rich fibrin (L-PRF) | Experimental | The L-PRF membrane was sutured to the palatal donor sites Receives: Procedure: Leucocyte and platelet rich fibrin membrane application |
| Control | No intervention | The palatal donor sites healed by secondary intention without L-PRF application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor site pain
Pain at the donor site was assessed using a VAS (Visual Analogue Scale) of 0-10.
Measured: Postoperative day 1 and weeks 1, 2, 3, and 4
Secondary outcomes (5)
Donor site burning sensation
Burning sensation at the donor site was assessed using a VAS(Visual Analogue Scale) of 0-10.
Measured: Postoperative day 1 and weeks 1, 2, 3, and 4
Donor site bleeding
Postoperative bleeding at the palatal donor site was assessed using a scale of 0 to 3: 0 = no bleeding, 1 = mild bleeding, 2 = moderate bleeding, and 3 = severe bleeding.
Measured: Postoperative days 1, 3, 5, and 7
Donor site color matching with the adjacent healthy tissue
The color matching of the donor site with the adjacent healthy tissue was assessed using a scale of 0 to 10: 0 = no match, 10 = perfect match.
Measured: Postoperative day 1 and weeks 1, 3, and 6
Donor site clinical healing
Clinical wound healing at the donor site was scored from 0 to 5 based on the consistency of the clinical appearance with the expected course of healing. Deviations from the expected appearance were recorded as "-1". The expected healing course was as follows: Days 1-7: Fibrin covers the wound surface with petechiae at the wound edge; Days 7-14: Decreased fibrin coverage; Days 14-21: Epithelialization of the defect area; Day 21 onwards: Complete healing.
Measured: Postoperative weeks 1, 2, 3, and 4
Donor site wound area
Donor site wound areas were measured digitally from standardized photographs taken using an occlusal mirror.
Measured: At baseline, on postoperative day 3, and at weeks 1, 2, 3, and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJan 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Gulsever, Istanbul Medipol University Hospital
- Investigators
- Serap Gulsever, DDS, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777069
- Sponsor's protocol ID
- IMUH-OMFS-SG-01
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are planning to share our data, after publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Palatal Wound Healing With Leucocyte- and Platelet-Rich Fibrin After Free Gingival Graft Harvesting: A Controlled Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06777069
- Acronym / sponsor ID
- IMUH-OMFS-SG-01
- Conditions
- Wound Healing
- Keywords
- free gingival graft, platelet rich fibrin, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autogenous palatal free gingival graft harvesting presents challenges for patients due to the increased risk of postoperative morbidity related to a second intraoral surgical wound that heals with secondary intention. This study aimed to evaluate the efficacy of the application of leukocyte- and platelet-rich fibrin (L-PRF) membrane to the palatal donor site on wound healing, hemostasis, and pain control after free gingival graft harvesting. Twenty-six adult patients with insufficient attached gingiva underwent soft tissue augmentation using free gingival grafts harvested from the palate. Patients were randomized to either an L-PRF group or a control group. In the L-PRF group, the L-PRF membrane was sutured to the donor sites, whereas in the control group, donor sites healed by secondary intention. Postoperative evaluations were conducted on days 1, 3, 5, and 7 and at weeks 2, 3, 4, 5, and 6. Donor sites were evaluated clinically for pain, burning sensation, bleeding, wound healing, and color match to adjacent tissues. Donor site wound areas were analyzed using digital images.
Detailed description
Soft tissue grafting techniques using autogenous free gingival grafts and connective tissue grafts are reliable and predictable procedures that are commonly used to increase the dimensions of keratinized gingiva. These tehniques are indicated in situations such as shallow vestibular depth, gingival recession, and inadequate peri-implant attached gingiva. Although free soft tissue grafts can be harvested from various intraoral sites, the keratinized gingiva of the hard palate in the premolar-molar region is the most commonly used donor site. However, harvesting tissue from the palate presents challenges for patients, including a second intraoral surgical wound and an increased risk of postoperative morbidity. The palatal wound, which typically heals over two to four weeks by secondary intention, often causes significant patient discomfort due to pain, burning sensation, prolonged bleeding, and delayed healing, often caused by secondary irritation.
Leukocyte- and platelet-rich fibrin (L-PRF), a second-generation platelet concentrate, was developed for oral and maxillofacial surgery in 2001 by Choukroun et al. Polymerization without any biochemical activation, which occurs in a manner comparable to the natural coagulation process, produces a strong fibrin matrix resistant to rapid resorption. Compressing this fibrin matrix creates a strong, suture-resistant membrane that can be fixed to the wound edges and provides a stable barrier against the oral environment.
While L-PRF has shown promise in several applications in regenerative dentistry, randomized controlled clinical trials evaluating L-PRF membrane as an adjunct for donor site wound healing in free gingival grafting procedures are limited in the literature. This study aimed to evaluate the efficacy of L-PRF membrane as a palatal wound dressing in promoting wound healing, hemostasis, and pain control at palatal donor sites following free gingival grafting procedures.
Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva were included in this study. Patients were randomized to either an L-PRF group (n=13) or a control group (n=13). All procedures were performed by a single clinician to reduce variability in surgical technique. After achieving adequate anesthesia, a recipient site was prepared to receive the graft in areas lacking sufficient attached gingiva. This procedure involved an incision at the mucogingival junction followed by blunt dissection to separate the epithelium from the underlying connective tissue, creating a vascular bed for graft integration and survival. A sterile paper template was created to match the dimensions of the recipient site. The paper template was positioned on the palatal mucosa in the premolar/molar region, and the graft margins were outlined with a scalpel. A 1-2 mm thick graft consisting of epithelium and a thin layer of connective tissue was carefully harvested by moving the blade parallel to the mucosal surface. The free gingival graft was carefully oriented on the recipient site, with the epithelium facing outward and the connective tissue in contact with the recipient bed. It was then sutured to ensure close contact between the graft and the underlying tissue to prevent any movement that could compromise revascularization and lead to graft failure. In the L-PRF group, 10 ml of venous blood was drawn from the antecubital vein of the patient using sterile, anticoagulant-free vacutainer tubes and immediately centrifuged at 3000 rpm for 10 minutes. A fibrin clot was structured in the middle of the tube, just between the red corpuscles at the bottom and the acellular plasma at the top. The L-PRF layer was isolated and compressed into a flexible membrane using its special box. The L-PRF membrane was shaped to fit the donor site wound and placed as a single layer, ensuring complete contact with the underlying tissue. It was secured at the wound corners using 5-0 bioabsorbable polyglactin sutures to minimize displacement during the healing process.
Participants were evaluated on days 1, 3, 5, and 7, and weeks 2, 3, 4, 5, and 6 postoperatively to monitor wound healing and complications at the palatal donor site. An examiner recorded subjective parameters (pain, burning sensation), clinically evaluated objective parameters (postoperative bleeding, wound healing, and color matching with the adjacent healthy tissue), obtained donor site photographs, and performed wound area measurements using digital image analysis. Blinding of patients to L-PRF treatment was not feasible due to ethical concerns regarding the collection of blood samples in the control group, and blinding of investigators during digital image analysis and clinical assessment was also not feasible due to the nature of the surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leucocyte and platelet rich fibrin (L-PRF) | Experimental | Procedure: Leucocyte and platelet rich fibrin membrane applicationThe L-PRF membrane was sutured to the palatal donor sites |
| Control | No intervention | –The palatal donor sites healed by secondary intention without L-PRF application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring soft tissue augmentation with a free gingival graft due to inadequate keratinized attached gingiva (shallow vestibular depth, gingival recession)
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Patients with systemic medical conditions that may compromise wound healing (e.g., uncontrolled diabetes mellitus, hypertension, blood disorders, rheumatoid arthritis)
- Patients receiving medication that may affect periodontal tissues (e.g., antibiotics, immunomodulatory drugs, steroids, non-steroidal anti-inflammatory drugs) within the last 3 months before surgery
- Patients receiving anticoagulant and antiaggregant therapy
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leucocyte and platelet rich fibrin membrane applicationLeukocyte and platelet rich membrane, obtained by centrifuging 10 ml of venous blood collected from the patient's antecubital vein, was sutured to the donor sites. | Procedure or surgery | Leucocyte and platelet rich fibrin (L-PRF) |
Primary outcome
Donor site pain
Time frame: Postoperative day 1 and weeks 1, 2, 3, and 4
Pain at the donor site was assessed using a VAS (Visual Analogue Scale) of 0-10.
5 secondary outcomes
Donor site burning sensation
Time frame: Postoperative day 1 and weeks 1, 2, 3, and 4
Donor site bleeding
Time frame: Postoperative days 1, 3, 5, and 7
Donor site color matching with the adjacent healthy tissue
Time frame: Postoperative day 1 and weeks 1, 3, and 6
Donor site clinical healing
Time frame: Postoperative weeks 1, 2, 3, and 4
Donor site wound area
Time frame: At baseline, on postoperative day 3, and at weeks 1, 2, 3, and 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Yes. We are planning to share our data, after publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap Gulsever, DDS, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucocyte and platelet rich fibrin membrane application in people with Wound Healing, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor site pain (time frame: Postoperative day 1 and weeks 1, 2, 3, and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.